← Back to Search

Surfactant

Surfactant Treatments for Meconium Aspiration Syndrome

Phase 3
Waitlist Available
Led By Patrick McNamara, MD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Infants ≥ 36 weeks gestational age with evidence of meconium aspiration syndrome
Be younger than 18 years old
Must not have
Surfactant administration prior to enrolment
Significant intracranial hemorrhage, defined as a unilateral or bilateral Grade III or IV intraventricular hemorrhage or a large intracranial, non-intraventricular hemorrhage
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will compare the effects of two different surfactant treatments for meconium aspiration syndrome.

Who is the study for?
This trial is for newborns at least 36 weeks old with meconium aspiration syndrome needing respiratory support within 6 hours of birth. They must be enrolled within a day of birth and have significant oxygenation difficulty, indicated by an OI > 15. Babies with likely intensive care withdrawal, hemodynamic instability on multiple inotropes, major congenital anomalies, certain heart diseases, prior surfactant use, severe pulmonary or brain hemorrhage can't participate.
What is being tested?
The study compares two treatments for babies with meconium aspiration: surfactant lavage versus bolus surfactant administration. It aims to see if lavage leads to faster improvement in lung function and shorter time on mechanical breathing support. This pilot will help decide if a larger trial is feasible and safe.
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical risks associated with surfactant therapy such as airway obstruction or changes in blood pressure and heart rate; the safety profile will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My baby was born at or after 36 weeks and has meconium aspiration syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have received surfactant treatment before joining.
Select...
I have not had a severe brain bleed.
Select...
My unborn baby has been diagnosed with a serious heart condition, not including minor issues like a small hole in the heart.
Select...
I have had severe lung bleeding that required more oxygen and showed on scans.
Select...
My illness is severe, needing advanced respiratory support.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
712 Previous Clinical Trials
6,959,391 Total Patients Enrolled
Patrick McNamara, MDPrincipal InvestigatorThe Hospital for Sick Children
1 Previous Clinical Trials
64 Total Patients Enrolled

Media Library

Bolus Surfactant (Surfactant) Clinical Trial Eligibility Overview. Trial Name: NCT00312507 — Phase 3
Meconium Aspiration Syndrome Clinical Trial 2023: Bolus Surfactant Highlights & Side Effects. Trial Name: NCT00312507 — Phase 3
Bolus Surfactant (Surfactant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00312507 — Phase 3
Meconium Aspiration Syndrome Research Study Groups:
~1 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top